Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baki Topal
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab; Gemcitabine; Tremelimumab

Criteria

Inclusion Criteria:

• Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017

• Histologically proven adenocarcinoma of the pancreas located in the head, body or tail

• LAPC tumor greatest diameter maximum 5 cm

• Male or female, age 18 years and older, ECOG PS 0-1

• Life expectancy of at least 12 weeks

• Only patients who did not receive chemotherapy for their PC are allowed

• Patients without distant organ metastases on conventional diagnostic imaging

• Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients

• Patients fit for MIS-MWA

• Able to receive Durvalumab and Tremelimumab.

• Patients with good liver and renal function and with good hematology

• Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.

• Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations

Exclusion Criteria:

• Pregnancy

• Metastatic PC on conventional diagnostic imaging or staging laparoscopy

• LAPC tumor greatest diameter is larger than 5 cm

• Borderline or resectable PC defined according to the NCCN guidelines version 2.2017

• Systemic chemo(radio)therapy is not allowed before MIS-MWA

• Major surgical procedure within 28 days prior to the first dose of investigational products

• Classic contraindications for PDL and CTLA antibodies